Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

For patients with burns of intermediate or indeterminate depth, what is the comparative effectiveness of an assessment method incorporating the moorLDI laser Doppler burns imaging system versus standard clinical assessment in improving health outcomes?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Assessment of burn depth using moorLDI2-BI laser Doppler burns imager versus standard visual clinical assessment or biopsy

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

All age ranges, genders, excluding patients with coexisting/preexisting vascular conditions, and excluding those with wound infection. The technology is only FDA-certified for burns of up to 30% TBSA.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Patients with Intermediate-depth burns.

Children: international studies suggest the moorLDI assessment system aids visual assessment to a greater extent in pediatric burns.

Children and the elderly: children and the elderly are (statistically) particularly vulnerable to burns and account for a disproportionate number of burns, as do low-income groups.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Improvements in assessment accuracy, leading to improved surgical planning, more appropriate (often smaller) graft area, in turn causing less pain and discomfort and leading to reduced scarring outcome (improved cosmetic outcome). Earlier and more accurate assessment leads to earlier average discharge from burn center.

Describe any health-related risks, side effects, or harms that you are concerned about.

Unnecessary surgery (grafting) of burn wounds where the tissue had potential to heal without surgery (i.e. could have been treated conservatively). Leads to unnecessarily increased healing time, pain, scarring, cost, risk of infection. There is a significant body of evidence that moorLDI use reduces this. If using biopsy to verify depth of burn, the measurement is only taken from a single point and thus is not representative of the whole burn area. It is also invasive and painful.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

AHRQ Priority Populations

• Low income groups
• Children
• Elderly

Federal Health Care Program

• Medicaid
• Medicare
• State Children's Health Insurance Program (SCHIP)

Importance

Describe why this topic is important.

Studies in the US and internationally have shown the moorLDI laser Doppler burn assessment system to promote earlier average patient discharge, reduce unnecessary grafting and improve confidence in healing predictions in indeterminate and intermediate depth burns.

Implementing the system in burn centers could potentially improve health and scarring outcomes in thousands of burn patients each year, as well as save Federal healthcare programs large sums of money through improved burn assessment, reduced unnecessary surgeries, shorter hospital stays, reduced scarring and hence less requirement for rehabilitative therapy.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

Several clinicians have commented publically and written in journals on the ‘guessing game’ involved in diagnosing mixed-depth, intermediate-depth and indeterminate-depth burns, and also on the variation in diagnosis between burn centers and between physicians; further, wrong diagnoses and the decision to graft a burn wound have been described as ‘the perfect crime’ on account of the difficulty verifying whether or not a graft was really necessary over the whole area grafted. Publications report use of moorLDI laser Doppler imaging in conjunction with clinical assessment can lead to improved assessment accuracy. Grafting can be reduced and in some cases avoided altogether. The pain and scarring caused by grafting (both at donor and graft sites), not to mention the cost, can in therefore be reduced and possibly avoided.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Several clinicians have commented publically and written in journals on the ‘guessing game’ involved in diagnosing mixed-depth, intermediate-depth and indeterminate-depth burns; further, wrong diagnoses and the decision to graft a burn wound have been described as ‘the perfect crime’ on account of the difficulty verifying the extent to which a graft was necessary (this is rarely a requirement and indeed there are few means to do this – a biopsy for example only tells you the burn depth at a single point) mean there is little to no pressure for clinicians to adopt this system despite its benefits. There have been suggestions by some clinicians that the potential for moorLDI to reduce patient volumes sent to surgery would reduce hospital revenue and thus the system’s adoption is opposed.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

n/a

Describe the timeframe in which an answer to your question is needed.

As soon as possible – a CER would be an excellent way to add to a growing body of evidence of the importance of this technique; the sooner this happens, the sooner burn patients can benefit from improved assessment and improved health outcomes. We hope that in the next few years this system begins to be adopted by burn centers nationally as it has internationally.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Children and the elderly are particularly vulnerable to burn injury, and there is evidence that the moorLDI system is particularly effective in improving early assessment accuracy in children. Low-income populations will also benefit from reduced costs due to shorter average hospital stay (as reported in publications)

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

n/a

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

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